Lower risk Medical device recall · FDA · Published May 16, 2018

Abbott C4 Diagnostic Assay Recall: Update Needed for Safety

Abbott recalls C4 diagnostic assay kits requiring updated instructions due to handling issues. Learn what to do if you have this product.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1992-2019Medical device Abbott ›

Lower-risk recall

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

Take action

Contact the company

Recalling firmAbbott Laboratories, Inc1921 Hurd Dr · Irving, TX 75038-4313

✎ GovInfoNow plain-language explainer

Abbott is recalling C4 diagnostic assay kits that require updated instructions for safe handling. This recall is needed to address potential issues with how the products are used. Read more at govinfonow.com/recall/71043-abbott-c4-diagnostic-assay-recall-update-needed-for-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/71043-abbott-c4-diagnostic-assay-recall-update-needed-for-safety · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1992-2019

Cite this page

“Abbott C4 Diagnostic Assay Recall: Update Needed for Safety.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71043-abbott-c4-diagnostic-assay-recall-update-needed-for-safety. Based on FDA recall #Z-1992-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1992-2019%22&limit=1).

The FDA announced on May 16, 2018, that Abbott Laboratories, Inc. recalled its C4 in vitro diagnostic assay kits due to required updates to the Instructions for Use (IFU). The recall affects 8,037 kits distributed nationwide and internationally.

How to tell if you have it

Brand: Abbott
Product: C4 in vitro diagnostic assay
Quantity: 8,037 kits

The hazard

The recall was issued because an update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. The C4 assay is used for the quantitative determination of C4 in human serum or plasma.

Context

GovInfoNow's records show Abbott Laboratories, Inc. has had 11 other recalls on record since September 29, 2017. Other recent recalls of similar products include Abbott Alinity s System Software Version 2.8.0 Recall (February 3, 2022), Abbott Alinity s System Recall (July 12, 2021), and Abbott ARCHITECT C System Mixer Recall (May 1, 2019). Other recent recalls of similar products include Abbott ID NOW Influenza A & B 2 Kit (February 9, 2026), AVID Medical Halyard IV Start Kit Recall (July 22, 2026), and Medline C-Section Kits Recall (July 10, 2026).

How to tell if you have this one

Check for C4 diagnostic assay kits from Abbott Laboratories. The product is used for measuring C as an antigen in blood samples.

Brand
Abbott
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom, Uruguay, and Viet Nam.

Recall number	Product, codes & lots	Quantity
Z-1987-2019	C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 in the sample.; All IFU's	8,132 kits
Z-1988-2019	Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.; All IFU's	12,995 kits
Z-1989-2019	Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.; All IFU's	11,063 kits
Z-1990-2019	Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin M in the sample.; All IFU's	9,586 kits
Z-1991-2019	Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.; All IFU's	2,112 kits
Z-1992-2019	C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.; All IFU's	8,037 kits
Z-1993-2019	The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming immune complexes . The immune complexes cause an increase in light scattering which correlates with the concentration of haptoglobin.; All IFU's	5,694 kits
Z-1994-2019	Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.; All IFU's	2,273 kits
Z-1995-2019	Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of transferrin in the sample.; All IFU's	22,359 kits

Based on the official FDA remedy

What to do — step by step

Review Instructions
Check if your C4 kit has updated instructions for safe handling as per the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.3 years after the firm started it.

May 16, 2018Firm started the recall
Jul 19, 2019FDA classified it Class II
Jul 31, 2019Published in FDA’s Enforcement Report
Aug 16, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71043-abbott-c4-diagnostic-assay-recall-update-needed-for-safety">Abbott C4 Diagnostic Assay Recall: Update Needed for Safety (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1992-2019 (May 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1992-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.